Patents: supplementary protection certificates

Background

The extension of patent protection for medicinal products  is governed by the Supplementary Protection Certificate (SPC) Regulation (469/2009/EC) (2009 Regulation).
One of the conditions for obtaining an SPC is that at the date of that application a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with the Medicinal Products Directive (2001/83/EC) (2001 Directive) or Directive 2001/82/EC (Article 3, 2009 Regulation) (Article 3).

Article 10(3) of the 2009 Regulation (Article 10(3) deals with corrections to a SPC application.

Facts

M owned a European patent for a drug which was used for the treatment of high cholesterol. 

M filed applications for marketing authorisations in a number of EU member states, including Germany and the UK. M also filed an application for an SPC with the UK Intellectual Property Office (IPO) on the day before the patent expired, in 2014. At that time M did not have a UK marketing authorisation. M relied on an email from the German Medicine Products Agency described as the "end of procedure communication of approval", which was issued in accordance with Article 28(4) of the 2001 Directive (Article 28(4)) before the expiry of the basic patent.

The IPO refused the application on the ground that it did not comply with Article 3(b) because there was no UK marketing authorisation at the date of the application. M appealed.

The IPO referred to the ECJ.

Decision

The ECJ ruled that an end-of-procedure notice issued in…